Lupin gets USFDA nod to market Tetrabenazine tablets

PTI New Delhi | Updated on April 23, 2018 Published on April 23, 2018

Drug firm Lupin today said it has received approval from the US health regulator to market in America its Tetrabenazine tablets used for the treatment of involuntary movements associated with Huntington’s disease. The company has received final approval to market the 12.5 mg and 25 mg tablets from the United States Food and Drug Administration (USFDA), Lupin said in a filing to BSE.

The tablets are generic versions of Valeant Pharmaceuticals North America LLC’s Xenazine tablets in the same strengths, it added. According to IQVIA MAT Jan 2018 data, Tetrabenazine tablets, 12.5 mg and 25 mg had annual sales of around $288.1 million in the US, Lupin said. The product is indicated for the treatment of chorea associated with Huntington’s disease, it added. Shares of Lupin Ltd were trading at Rs 808.80 per scrip on BSE, up 1.31 per cent from its previous close.

Published on April 23, 2018
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